Our Services and Methodology
KAI staff provide initial and ongoing support to investigative sites during clinical trial implementation and throughout the study life cycle. We understand the need for quality sites and well-trained professionals to conduct well-run clinical trials that produce accurate results while protecting the rights of human subjects. Our experienced project managers, clinical research associates, and research assistants/associates are well-versed in the clinical research continuum and apply evidence-based processes to initiate studies, select and manage sites, conduct training, and monitor sites for both government and industry trials. We also assist sites to identify catchment areas, develop recruitment plans, implement retention strategies, and track all study activities. Projects range from simple, single-site, open-label studies to phase II and phase III randomized placebo-controlled trials with various designs. We have successfully managed trials which have changed protocols mid-study, requiring extensive manual of operating procedures modifications and retraining. Our documented processes have been reviewed and approved by U.S. Food and Drug Administration auditors, and we abide by the highest standards for documentation and clinical trial ethics.
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